Using a nasal swab test to manage patients with pulmonary nodules
Clinical Utility of Management of Patients With CT and LDCT Identified Pulmonary Nodules Using the Percepta Nasal Swab Classifier
This study is testing if a nasal swab test can help doctors make better decisions for patients with newly found lung nodules, potentially reducing unnecessary procedures for low-risk cases and speeding up treatment for high-risk cases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 29 Years to 85 Years |
| Sex | All |
| Sponsor | Veracyte, Inc. Industry-sponsored |
| Locations | 23 sites (Hartford, Connecticut and 22 other locations) |
| Trial ID | NCT06426628 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how the Percepta® Nasal Swab test results influence the management of patients with newly identified pulmonary nodules. Participants will be randomly assigned to either a test group, where their test results are shared with their physician, or a control group, where results are not disclosed. The study will assess whether the test reduces the need for invasive procedures in low-risk cases and speeds up treatment for high-risk cases. Approximately 2400 participants will be enrolled across up to 100 centers in the US, with follow-up lasting 24 to 30 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 29 to 85 with a newly identified pulmonary nodule and a history of smoking.
Not a fit: Patients with active cancer or prior primary lung cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and efficient management of pulmonary nodules, potentially reducing unnecessary procedures and expediting treatment for lung cancer.
How similar studies have performed: Other studies have shown promise in using similar diagnostic approaches to improve management of lung nodules, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to tolerate nasal epithelial specimen collection * Signed written Informed Consent obtained * Subject clinical history available for review by sponsor and regulatory agencies * New nodule identified on imaging \< 90 days prior to nasal sample collection * CT report available for index nodule * 29 - 85 years of age * Current or former smoker (\>100 cigarettes in a lifetime) * Pulmonary nodule ≤30 mm detected by CT Exclusion Criteria: * Active cancer (other than non-melanoma skin cancer) * Prior primary lung cancer (prior non-lung cancer acceptable) * Prior participation in this study (i.e., subjects may not be enrolled more than once) * Current active treatment with an investigational device or drug * Patient enrolled or planned to be enrolled in another clinical trial that may influence management of the patient's nodule * Concurrent or planned use of tools or tests for assigning lung nodule risk of malignancy other than clinically validated risk calculators
Where this trial is running
Hartford, Connecticut and 22 other locations
- Trinity Health Of New England — Hartford, Connecticut, United States (Recruiting)
- The Stamford Health/The Stamford Hospital — Stamford, Connecticut, United States (Recruiting)
- Bay Pines VA HCS — Bay Pines, Florida, United States (Recruiting)
- North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States (Recruiting)
- Bruce W. Carter Miami VA Medical Center — Miami, Florida, United States (Recruiting)
- Orlando VA Healthcare System — Orlando, Florida, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- OSF Saint Francis Medical Center — Peoria, Illinois, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Lexington VA Health Care System — Lexington, Kentucky, United States (Recruiting)
- Robley Rex VA Medical Center — Louisville, Kentucky, United States (Recruiting)
- Southeast Louisiana Veterans Health Care System — New Orleans, Louisiana, United States (Recruiting)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
- Boston University Medical Center — Boston, Massachusetts, United States (Recruiting)
- Saint Lukes Hospital — Kansas City, Missouri, United States (Recruiting)
- Mercy Hospital — Springfield, Missouri, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- Good Samaritan Cancer Center — West Islip, New York, United States (Not_yet_recruiting)
- PulmonIx, LLC — Greensboro, North Carolina, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Mercy Health St. Vincent Medical Center — Toledo, Ohio, United States (Recruiting)
- Ralph H. Johnson VA Health Care System — Charleston, South Carolina, United States (Recruiting)
- VA Caribbean Healthcare — San Juan, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: Lori Lofaro, MSHS
- Email: lori.lofaro@veracyte.com
- Phone: 6502436389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.